A 12-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 ?g of OPN-375 Twice a Day (BID) in Adolescent Subjects with Chronic Rhinosinusitis Without Nasal Polyps

This is a 12-Week randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy and safety of intranasal administration of 186 µg of OPN-375 twice a day (BID) in adolescent subjects with chronic rhinosinusitis without nasal polyps. The total planned number of subjects is approximately 84 adolescents (12-17 years of age) who will be randomly assigned to receive 1 of 2 study treatments using a 1:1 ratio (OPN-375 186 µg:placebo). The study includes a PK sub-study, in which up 14 subjects will be enrolled to obtain 10 completers.

Study ID: 5169
NCT Number: NCT06850805
Principal Investigator: Christine Franzese, MD
Department: Otolaryngology
Eligibility: Both men and women 12 years old to 17 years old. Accepts healthy volunteers.

For questions about this study, please contact:

ClinicalTrialsInterest@health.missouri.edu
(573) 882-7026